MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR

System, Catheter Control, Steerable

HANSEN MEDICAL, INC.

The following data is part of a premarket notification filed by Hansen Medical, Inc. with the FDA for Magellan Robotic System, Magellan Robotic Catheter 9fr.

Pre-market Notification Details

Device IDK132369
510k NumberK132369
Device Name:MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR
ClassificationSystem, Catheter Control, Steerable
Applicant HANSEN MEDICAL, INC. 800 EAST MIDDLEFIELD ROAD Mountain View,  CA  94043
ContactHassan Labay
CorrespondentHassan Labay
HANSEN MEDICAL, INC. 800 EAST MIDDLEFIELD ROAD Mountain View,  CA  94043
Product CodeDXX  
CFR Regulation Number870.1290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-07-30
Decision Date2013-09-27
Summary:summary

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